Cleared Traditional

TRANSFERMETER

K863066 · J. D. Assoc. · Chemistry
Dec 1986
Decision
114d
Days
Class 1
Risk

About This 510(k) Submission

K863066 is an FDA 510(k) clearance for the TRANSFERMETER, a Bathophenanthroline, Iron Binding Capacity (Class I — General Controls, product code JQF), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 4, 1986, 114 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K863066 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 1986
Decision Date December 04, 1986
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQF — Bathophenanthroline, Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415